Building knowledge, optimising physical and mental health and setting up healthier life trajectories in South African women (Bukhali): a preconception randomised control trial part of the Healthy Life Trajectories Initiative (HeLTI)

Abstract

IntroductionSouth Africa’s evolving burden of disease is challenging due to a persistent infectious disease, burgeoning obesity, most notably among women and rising rates of non-communicable diseases (NCDs). With two thirds of women presenting at their first antenatal visit either overweight or obese in urban South Africa (SA), the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and NCDs.Methods and analysisBukhali is the first individual randomised controlled trial in Africa to test the efficacy of a complex continuum of care intervention and forms part of the Healthy Life Trajectories Initiative (HeLTI) consortium implementing harmonised trials in Canada, China, India and SA. Starting preconception and continuing through pregnancy, infancy and childhood, the intervention is designed to improve nutrition, physical and mental health and health behaviours of South African women to offset obesity-risk (adiposity) in their offspring. Women aged 18–28 years (n=6800) will be recruited from Soweto, an urban-poor area of Johannesburg. The primary outcome is dual-energy X-ray absorptiometry derived fat mass index (fat mass divided by height2) in the offspring at age 5 years. Community health workers will deliver the intervention randomly to half the cohort by providing health literacy material, dispensing a multimicronutrient supplement, providing health services and feedback, and facilitating behaviour change support sessions to optimise: (1) nutrition, (2) physical and mental health and (3) lay the foundations for healthier pregnancies and early child development.Ethics and disseminationEthical approval has been obtained from the Human Ethics Research Committee University of the Witwatersrand, Johannesburg, South Africa (M1811111), the University of Toronto, Canada (19-0066-E) and the WHO Ethics Committee (ERC.0003328). Data and biological sample sharing policies are consistent with the governance policy of the HeLTI Consortium (https://helti.org) and South African government legislation (POPIA). The recruitment and research team will obtain informed consent.Trial registrationThis trial is registered with the Pan African Clinical Trials Registry (https://pactr.samrc.ac.za) on 25 March 2019 (identifier: PACTR201903750173871).Protocol version20 March 2022 (version #4). Any protocol amendments will be communicated to investigators, Institutional Review Board (IRB)s, trial participants and trial registries.

Evaluation of a Text Messaging Intervention to Promote Preconception Micronutrient Supplement Use: Feasibility Study Nested in the Healthy Life Trajectories Initiative Study in South Africa

“…This study was nested in the intervention group of the South African site of the HeLTI Bukhali study, a randomized controlled trial that aimed to evaluate a multifaceted intervention for promoting the health of women of reproductive age (18-28 years) [30,31]. Similar trials are ongoing in Canada, India, and China in collaboration with the World Health Organization.…”

“…• SMS text messages were automatically sent twice a week to participant phone numbers, using Twilio Inc, and airtime was supplied automatically using FlickSwitch Control South Africa (Cape Town). The intervention evaluation was nested in the HeLTI South Africa Bukhali trial, which evaluates a complex intervention (education, social support, behavior change, and micronutrient supplement) [30,31].…”

Cross-sectional associations between mental health indicators and social vulnerability, with physical activity, sedentary behaviour and sleep in urban African young women

“…The Healthy Life Trajectories Initiative (HeLTI) is a multi-country study aimed at establishing a programme of research to generate evidence on intervening to optimise young women’s physical and mental health, and to establish healthier trajectories for themselves and potential future offspring, including reduced risk for NCDs [ 38 ]. As part of HeLTI, it is essential to understand NCD risks in young women, and how these might be mitigated through health behaviour change as well as mental health support.…”

A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa

“…The Healthy Life Trajectories Initiative (HeLTI) South Africa (SA) is one site of the multinational HeLTI consortium, with complementary trials ongoing in Canada, India, and China, in collaboration with the World Health Organization. HeLTI aims to evaluate the cumulative effect of a complex package of interventions starting in the preconception period, through pregnancy and early childhood on childhood obesity as the primary outcome [ 10 , 11 ]. Obesity and non-communicable diseases are rapidly increasing in South Africa and other settings undergoing epidemiological transitions [ 12 , 13 ].…”

“…Due to the multifaceted nature of the HeLTI SA intervention [ 11 ], fidelity assessment and reporting is important for the interpretation of the trial results. Our qualitative research has indicated that young women living in Soweto (trial setting) face significant difficulties, such as poverty, interpersonal and family-related issues, and the impact of traumatic events [ 17 ].…”